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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 021937

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NDA 021937 describes ATRIPLA, which is a drug marketed by Gilead Sciences and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ATRIPLA profile page.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for 021937

Tradename:	ATRIPLA
Applicant:	Gilead Sciences
Ingredient:	efavirenz; emtricitabine; tenofovir disoproxil fumarate
Patents:	7

Pharmacology for NDA: 021937

Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 021937

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937	NDA	Gilead Sciences, LLC	15584-0101	15584-0101-1	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15584-0101-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG;200MG;300MG
Approval Date:	Jul 12, 2006	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Jan 13, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HIV-1 INFECTION IN ADULTS
Patent:	⤷ Subscribe	Patent Expiration:	Jan 13, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Patent:	⤷ Subscribe	Patent Expiration:	Apr 28, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021937

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Subscribe	⤷ Subscribe
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Subscribe	⤷ Subscribe
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Subscribe	⤷ Subscribe
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Subscribe	⤷ Subscribe
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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